NCT00303069

V710 First-In-Man (FIM) Study (V710-001)

A Sequential-Panel, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine in Healthy Adults 18 to 55 Years of Age

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, Multicenter, double-blind (subject, investigator, and Merck Research Laboratories (MRL) clinical personnel directly involved in the study), placebo-controlled, dose-ranging study in healthy adults 18 to 55 years of age. It is the first in man (FIM) study evaluating the tolerability and immunogenicity of the 0657nI S. aureus vaccine. For this Phase I study, approximately 120 healthy adults will be enrolled in the study and randomized to receive a single 0.5 mL vaccination of either 0657nI S. aureus vaccine (3 different dosage levels of 5 μg, 30 μg or 90 μg of the 0657nI vaccine) or saline placebo. Vaccine/placebo will be administered intramuscularly (IM) in the deltoid muscle. Because this study will be the first study evaluating the tolerability and immunogenicity of 0657nI S. aureus vaccine in humans, a dose-escalation phase will be conducted in a small number of subjects randomized in a 3:1 ratio (n=36, consisting of 9 subjects for each of 3 vaccine dosage levels and 9 placebo subjects) to evaluate the vaccine safety at increasing dose levels of the 0657nI protein in Panel A, before expanding the enrollment to the remaining 84 subjects in Panel B.

Detailed description

Depending on when the subject is enrolled into the study, the following will be completed: The subject will receive a single injection of SAV or placebo (an inactive substance) in the deltoid muscle of the upper arm. The subject will then be watched for 30 minutes after vaccination to monitor for allergic reactions. The subject will be asked to visit the study doctor either 6 or 9 times during the 3-month study period. Once enrolled, the subject will have blood drawn before receiving the vaccine (baseline) and up to 7 times after that at each of the required visits. The blood will be used for tests and/or for testing the subject's body's immune response to the SAV, to see if the subjects have developed immunity to S. aureus and if immunity continues up to 84 days. A Vaccination Report Card (VRC) will be provided to all participants. The participant will be asked to record oral temperatures and any reactions that occur at the SAV injection site every day for 5 days after vaccination. The participant will also be asked to record any physical adverse effects that they may experience, including headaches, nausea, muscle pain or aches, and fatigue every day for 14 days after vaccination. In additional all medications (including over the counter medications) taken during the 14 days post vaccination will be recorded and the VRC will be returned to the research staff after 14 days.

Conditions

• Staphylococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	V710	Single dose of V710 (at dosages of 5 μg, 30 μg, or 90 μg) intramuscularly
BIOLOGICAL	Comparator: Placebo	Single dose of saline placebo intramuscularly

Timeline

• Start date: 2005-11-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2006-03-15
• Last updated: 2015-07-22
• Results posted: 2010-10-20